About 15 years ago, as the first wave of AIDS drugs began showing promise for adults, researchers at sites across the country, including Johns Hopkins University and the University of Maryland, began testing the drugs on HIV-infected children -- some of them foster children.
Now, questions have been raised about whether those foster children were adequately protected by law when they became involved in the clinical trials of potentially lifesaving medications. Yesterday, a congressional subcommittee quizzed researchers and ethicists in search of answers.
"Those trials involved both hope and risk," said U.S. Rep. Wally Herger (R-Calif.), who chaired the House Ways and Means subcommittee hearing. "Concerns have been raised about the right balance between hope and risk and who gets to make that critical decision."
Yesterday's inquiry was prompted by an Associated Press investigation published this month which reported that the research -- funded by the National Institutes of Health and conducted in at least seven states -- involved hundreds of foster children, often without providing them with independent medical advocates to oversee their treatment.
Virginia and the District were not listed as participating in the trials.
"The research . . . was most widespread in the 1990s as foster care agencies sought treatments for their HIV-infected children that weren't yet available in the marketplace," the AP reported. Some foster children died during the trials, according to the wire service, but no records were found to indicate that the deaths were directly attributable to the treatments.
The U.S. Office for Human Research Protections, an arm of the Department of Health and Human Services, has undertaken an investigation of the use of foster children in the AIDS trials. And during yesterday's hearing, lawmakers discussed a patchwork of state policies regarding the involvement of foster children in clinical trials. They learned that in trials where institutional review boards determine that child patients will face minimal risk or are expected to draw direct benefit from the research, no independent medical advocate is required to oversee their care.
Such was the case in Maryland, officials said in recent interviews at the University of Maryland School of Medicine in Baltimore and Johns Hopkins Children's Center.
John J. Farley, associate professor of pediatrics at the U-Md. School of Medicine, said federal regulations should be revised to require such advocates. But he noted that they were not required for the AIDS trials done at U-Md. 15 years ago and were not appointed.
He said fewer than a dozen foster children were involved in the U-Md. trials. Some trials involved breakthrough treatments such as AZT used in combination with another drug. Other trials did not involve medications at all. No foster child was involved in placebo-controlled trials, he said, nor did any die as a result of involvement in the trials.
"I join with my colleagues in feeling they weren't exploited and probably a number of those children are alive today because they had access to those medications," Farley said.
In a statement, Johns Hopkins Medicine said advocates were not required in its research. A spokeswoman declined to provide further information about the children involved in trials there, citing confidentiality.
A spokeswoman at the Maryland Department of Human Resources was unable to say how many foster children in the state were involved in the trials. Department spokesman Norris P. West stressed that they must be viewed in the context of the late 1980s and early 1990s, when a million Americans were estimated to be HIV-positive and the cocktails of drugs that now are regularly prescribed to delay the onset of full-blown AIDS were still on the horizon.
"That was a time when we were desperately looking for something that would slow down the rapid pace and spread of AIDS, including among children," West said in an interview.
"Fifteen years later, looking back it might seem: 'What were they thinking? How could they test kids like that?' At the time, there wasn't a moral dilemma. It was watching a child die."
Deborah Weimer, a University of Maryland law professor and director of the college's AIDS legal clinic, said that in those days, she was worried that foster children were being shut out of AIDS trials because of legal impediments in the system that was supposed to be protecting them.
On a similar note, Moira Ann Szilagyi, a pediatrician testifying on behalf of the American Academy of Pediatrics yesterday, said, "While the headlines seem to suggest that children in foster care were somehow singled out as hapless guinea pigs . . . numerous legal barriers exit for children in foster care even to obtain routine health care."
Still, Rep. Fortney "Pete" Stark (D-Calif.) contended that prisoners involved in medical research have advocates to oversee all participation in medical trials. He suggested that future legislation include similar uniform protections for foster children.
"I think we'd sleep a little better at night if we put in a requirement that children have sufficient advocacy," he said.
